End of Procedure Notice Not Sufficient to Save an SPC
The CJEU has confirmed in Decision C-567/16 that an “end of procedure notice” issued by a reference Member State under the decentralised procedure is not equivalent to a marketing authorisation required by Article 3(b) of the SPC Regulation 469/2009 (“the SPC Regulation”).
To secure a Supplementary Protection Certificate (SPC) for a medicinal product Article 3(b) of the SPC Regulation requires there to be a valid authorisation to place the medicinal product on the market as a medicinal product. In addition, Article 3(a) requires there to be a basic patent in force which protects the medicinal product at the time the SPC application is filed.
This proved to be a challenge for Merck Sharp & Dohme Corporation (“MSD”) for its product Atozet®, because the European patent MSD wanted to use for its SPC application was very close to its expiry date, but MSD had not yet received the formal marketing authorisation to place Atozet® on the market in the UK.
MSD’s European patent expired on 13 September 2014. MSD had used the decentralised procedure to obtain regulatory approval of Atozet®. The German regulatory authority had issued an end of procedure notice on 10 September 2014. One day before the MSD patent expired the French national authority issued the first marketing authorisation to place Atozet® on the market in the EU. However, MSD had not yet received the formal marketing authorisation from the UK MHRA.
MSD decided to file an application for an SPC on the last day on the European patent and in its application referred to the first approval of Atozet® in France and provided a copy of the end of notice period in lieu of the formal UK marketing authorisation. The MHRA issued the UK marketing authorisation shortly afterwards on 10 October 2014.
The UKIPO rejected MSD’s SPC application on the ground that application did not comply with Article 3(b) of the SPC Regulations because there was no valid marketing authorisation for Atozet® when the SPC application was filed. As is often the case with SPC case law in Europe, different member states had come to different conclusions on this point. Portugal and Sweden followed the UKIPO interpretation and rejected the SPC application, whereas Denmark, Greece, Italy and Luxembourg allowed the SPC. The Netherlands also found that the end of procedure notice was sufficient, but rejected the SPC application on another ground.
MSD appealed the UKIPO decision and this ultimately led to a referral to the CJEU.
After consideration of the SPC Regulation, and particularly the decision in Forsgren (C‑631/13), the CJEU held that an end of procedure notice is not equivalent to a marketing authorisation and as such an SPC may not be based on an end of procedure notice. The CJEU also rejected the possibility of rectifying the deficiency in the SPC application under Article 10(3) of the SPC Regulation.
This is a tough decision for innovator pharmaceutical companies. The purpose of the SPC Regulation is to compensate patent holders for the time taken to obtain authorisation for medicinal products (Recitals 4 and 5 of the SPC Regulation). In this case MSD was unable to obtain any commercial benefit from the European patent covering Atozet®. Had the UK marketing authorisation been issued at the same time as the French authorisation MSD would have obtained the maximum 5 year SPC term.
In the US the Hatch-Waxman Act allows for “interim extension” of patent term (37 CFR 1.750). This enables applicants to apply for an interim extension is to maintain the patent term until regulatory approval for the product is obtained. An application for an interim extension can be submitted in the last 6 months of the patent term (up to 15 days before the patent expiry). The term of an interim extension is limited to one year. However, the applicant may apply for up to four subsequent interim extensions. Once FDA approval is obtained a regular patent term extension application is made.
The European Commission are currently undertaking a consultation process to gather feedback on the way the current SPC works and will consider whether the EU SPC framework is still fit for purpose or needs to be amended (Commission Consultation). The deadline for submissions to the Commission consultation is 4 January 2018.
If the Commission ultimately implement changes to the SPC Regulations, the introduction of interim protection provisions similar to those in the USA would be a welcome addition for patent holders.